If passed, the law would allow sterile drug compounding facilities to register as “outsourcing facilities,” which would be subject to oversight by the Food and Drug Administration.
Such facilities would have to comply with certain manufacturing practices, event reporting, risk-based inspections and labeling requirements.
The bill proposes a system for stronger communication between the FDA and states during problems related to compounded drug products. A “track and trace” provision would implement a serial number system to track prescription drugs from the manufacturer to the dispenser
The bill also mandates stronger licensure requirements for third-party logistics providers and wholesale distributors.
The bill will now travel to the Senate.
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